Immunotherapy Bavencio coverage green lit for skin cancer

HIRA unveils amended anticancer reimbursement standard including Bavencio single therapy coverage

New standard also stipulated exempted case of off-label chemotherapy use

The South Korean health authority has granted reimbursement on Merck’s immunotherapy Bavencio injection (avelumab).

 

The Health Insurance Review and Assessment Service (HIRA) plans to accept public opinion on the unveiled revised Notice on Pharmaceuticals for Cancer Patient’s Prescription and Administration until Sept.

 

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Without much of objection, the reimbursement would be granted from Oct.

 

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Bavencio was initially approved as a single agent therapy to treat adult patients with metastatic Merkel cell carcinoma (MCC).

 

The treatment is now listed as a second-line treatment in adult patients with metastatic MCC, who have not been treated with immune checkpoint inhibitor like a PD-1 inhibitor.

 

To expand the treatment’s reimbursement standard, HIRA has confirmed the National Comprehensive Cancer Network (NCCN) guideline recommending Bavencio as Category 2A for treating patients with metastatic MCC, based on a single-arm, open-label Phase II trial findings on the treatment’s efficacy in patients aged over 18 with Stage IV MCC progressed after receiving one or more anticancer therapy, which demonstrated median overall survival (mOS) of 12.9 months, median progression-free survival (mPFS) of 2.7 months, and overall response rate (ORR) of 33.0 percent.

 

The reimbursement decision was passed as a retrospective observational study on MCC patients who have used second-line or later chemotherapy that found the treatment’s improved clinical efficacy compared to mOS 5.7 months, mPFS 2.0 months and ORR 23 percent.

 

However, the general immune checkpoint inhibitor reimbursement condition, ‘to be used only in healthcare institutes capable of responding on emergency cases of unpredicted adverse reaction, and administered by a well-experienced doctor with sufficient knowledge in anticancer therapies,’ would be applied the same.

 

And also the healthcare benefit would be limited to patients who have not been treated with other PD-1 inhibitor-like immune checkpoint inhibitor.

 

Now the reimbursed use of Bavencio would be available to patients with MCC, as well as basal cell skin cancer and squamous cell skin cancer.

 

Also, HIRA clarified the off-label chemotherapy use evaluation standard and exempted case of post-approval (use prior to HIRA president’s approval) with the new notice the agency disclosed.

 

Previously, the standard only stipulated a healthcare institute meaning to use off-label chemotherapy to undergo review by a multidisciplinary review board and request an approval by the president of HIRA via template application for off-label use of chemotherapy supplemented with evidential data.

 

Nonetheless, the amended standard added new standard for the president of HIRA to either dismiss or return the off-label use application, if the required evidential data is not submitted.

 

And the applicable healthcare institute would be not allowed to request or use off-label chemotherapy in following cases; an alternative standard of care exists within the scope of notified, approved or already-recognized off-label therapy; inevitability or medical necessity cannot be proven; the off-label use is for supplementary or maintenance therapy before or after a surgery; and use of an off-label cancer therapy seeking for the approval has been rejected previously after a review.

 

Meanwhile, the stipulated re-assessment period clause—‘the president of HIRA should constantly monitor the system execution status, and re-assess relevant laws and environment at a one-year point since the regulation is notified, to reflect needed changes until the two-year point of the regulation’—was removed.

 

HIRA official said, “As the progress and status are reported to Cancer Disease Deliberation Committee, the agency decided to delete the regulation on the re-assessment period after reviewing the public opinion.”